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Evaluering af PPAL

2. november 2026 opdateret af: Alicia Koontz

Udvikling og evaluering af PPAL-sengebordskommode til sikre selvstændige toiletoverførsler

This research study is being conducted to better understand the impact of the PPAL assisted toileting device. The PPAL consists of a powered, height-adjustable commode chair with integrated transfer boards. The system is designed to allow users to assist with their own transfers to and from the bed or chair to the PPAL for toileting, with minimal manual assistance from caregivers. Users who require assistance with transfers, and their caregivers, have a high likelihood of experiencing injury during transfers.

The purpose of this study is to evaluate the PPAL bedside commode in a home setting to better understand the impact of the device during a six-week at-home trial. Participants will be asked to schedule a home visit with the research team to screen their home, answer questions, and observe the participant's current transfer methods to their toilet or commode to ensure that both the participant and caregiver are appropriate candidates for the device. Once approved, a delivery date will be arranged to deliver the PPAL to the participant's home. At the end of the six-week trial, the study team will arrange a final visit to retrieve the PPAL and again ask questions and observe a toilet transfer using both the PPAL and the customary commode. Finally, the investigators will interview the participant and caregiver to assess their satisfaction with the device. This interview will be audio recorded.

This study involves minimal risks, which are expected to occur infrequently. There is a possibility that the participant could experience a scrape, bruise, cut, or pinch injury while using a device with which they are not familiar. There is also the possibility that the participant could fall when attempting to transfer to or from the device; however, the investigators will thoroughly demonstrate the device and monitor its use to minimize this risk. There is also a risk of breach of confidentiality, as text messages and emails may not be encrypted or secure during transmission or storage, and it is possible they could be intercepted or accessed by individuals not associated with this study.

There will be no direct benefit to the participant from participating in the study, but participation will help developers of the PPAL better understand the opinions, needs, and abilities of caregivers and patients who may use the device.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Nikitha Deepak, MS
  • Telefonnummer: 412-822-3669
  • E-mail: NID51@pitt.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • Rekruttering
        • University of Pittsburgh: Human Engineering Research Laboratories
        • Ledende efterforsker:
          • Alicia Koontz, PhD
        • Kontakt:
          • Nikitha Deepak, MS
          • Telefonnummer: 412-407-2047
          • E-mail: NID51@pitt.edu
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Toileter Inclusion Criteria:

  • Age 18 years or above
  • Weighs 300 pounds or less and is able to fit within the dimensions of the PPAL - Has difficulty with getting on or off a toilet or commode at any point in a typical 24-hour period
  • Resides in either a home, independent living residence, assisted living or extended care residence
  • Able to maintain sitting balance independently (without human assistance) for at least 2 minutes
  • If sitting for longer than 2 minutes (with or without assistance), does not get dizzy or lightheaded
  • Residence is able to accommodate the PPAL in the Bedroom or designated space.

Toileter Exclusion Criteria:

  • Ventilator users
  • Free of acute medical events within the last 3 months
  • Had Stage 2 or greater pressure ulcer within the last 3 months
  • Upcoming planned medical procedures or surgeries in the next 3 months.

Caregiver Inclusion Criteria:

  • Age 18 years or above
  • Formal/paid or informal/unpaid caregiver for the patient participant (toileter) who provides toileting assistance at least 3 days per week

Caregiver Exclusion Criteria:

-Physical limitations that prevent caregiver from manually assisting with PPAL transfer or from maneuvering the PPAL around the end-user's residence

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PPAL-bruger
Enhed: PPAL

PPAL is a patented, motorized, height adjustable bedside commode with integrated transfer boards. PPAL incorporates a transfer board that moves up and down as the chair seat is raised or lowered so that the user can always perform a downhill transfer. This innovation will allow individuals with limited mobility who currently rely on caregiver assistance to transfer more independently.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fall efficacy with connection to toileting
Tidsramme: Change from pre to post 6 week trial

We aim to determine whether the use of PPAL reduces fear of falling during toileting activities. To assess this, we will utilize the Fall Concerns Scale for individuals who use Wheelchairs and Scooters (FCS-WC/S). Items are scored on a scale of concern, with 1 being "Not at all concerned" and 4 being "Very Concerned". Scores can be analyzed from specific questions, or the questionnaire as a whole. For this result we will focus on the item specifically associated with getting on/off of a toilet or commode at home. A decrease in FCS-WC/S scores at the end of the study would indicate a reduction in fear of falling.
Change from pre to post 6 week trial

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in GG Self-Care score for Toilet Transfer
Tidsramme: Change from pre to post 6 week trial

We aim to observe a change in the GG Self-Care score for toilet transfers, specifically an improvement in the individual's ability to safely get on and off a toilet or commode. This item is scored on a scale from 1 (Dependent: completely reliant on a caregiver) to 6 (Independent: no assistance required). An increase in this score would indicate improved functional independence.
Change from pre to post 6 week trial
System Usability Scale (SUS)
Tidsramme: At the end of the 6 week trial

We aim to find that PPAL will have at minimum an acceptable level of usability at the end of the trial. The SUS consists of items rated on a scale of 1 (strongly disagree) to 5 (strongly agree), assessing the participants perceived usability of the system in several domain areas. A total score is computed and a score of 68 or higher would be indicative of acceptable usability (scores ranging from 0 to 100 with higher scores indicating better usability).
At the end of the 6 week trial

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alicia Koontz

Samarbejdspartnere

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
QUA Inc.

Efterforskere

  • Ledende efterforsker: Alicia M Koontz, PhD, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. januar 2026

Primær færdiggørelse (Anslået)

20. november 2026

Studieafslutning (Anslået)

20. november 2026

Datoer for studieregistrering

Først indsendt

24. oktober 2025

Først indsendt, der opfyldte QC-kriterier

24. oktober 2025

Først opslået (Faktiske)

28. oktober 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY25100178
  • 5R44NR019516-03 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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